Validation of a Novel Non-invasive Continuous Blood Pressure Monitor in Children Ages 2- 17 Years-old

Boston Children's Hospital

Status: Active, not recruiting

Conditions: Blood Pressure

Treatments: Device: CareTaker PDA Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04817137

IRB-P00037138

Details and patient eligibility

About

This is a prospective observational study to investigate if a non-invasive blood pressure monitoring device, the CareTaker Pulse Decomposition Analysis (PDA), can accurately measure blood pressure in children when compared to an arterial line. Enrolled patients will have the CareTaker PDA device placed on their finger during their operation to collect data for 30 minutes. Blood pressure readings from the CareTaker PDA device will be compared to measurements from the patient's indwelling arterial line, which will be placed as part of the patient's clinical care plan.

Enrollment: 35 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Plan to receive an invasive arterial blood pressure monitor as part of their anesthesia care plan at the BCH Longwood campus

Exclusion criteria

• Patients with vascular or congenital heart disease known to affect large and small arteries
• Patients who declined to participate.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

All Enrolled Patients

Other group

Description:

Patients will wear the Caretaker Pulse Decomposition Analysis (PDA) Device, which will record the patient's blood pressure.

Treatment:

Device: CareTaker PDA Device